HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP Adverse Event — Death (MDR 3007042319-2020-03006)
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP Adverse Event — Death (MDR 3007042319-2020-03006) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: HEARTWARE, INC..
| Device | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | HEARTWARE, INC. |
| Report number | 3007042319-2020-03006 |
| Event type | Death |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | IT WAS FURTHER REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED SOME LOW FLOWS AND THE PATIENT'S LACTATE DEHYDROGENASE LEVELS WERE NORMAL. A REPEAT COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED HIGH SUSPICION OF A CLOT WITHIN THE VAD OUTFLOW CANNULA. NO INTERVENTION WAS TAKEN AT THE TIME AND THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY. |
| Source | openFDA MAUDE (device adverse events) |
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